A Multi-centre Trial to Assess the Efficacy and Safety of the Omnipod 5 System in People With Type 2 Diabetes Undergoing Haemodialysis (AID-HD)

An Open-label, Multi-centre, Randomised Controlled Trial to Assess the Efficacy, Safety and Utility of Automated Insulin Delivery in People With Type 2 Diabetes and Sub-optimal Glycaemia Undergoing Haemodialysis

Diabetes is the leading cause of kidney failure in the UK. Many people with diabetes and advanced kidney failure inject themselves with insulin and do finger-prick blood glucose tests. Managing diabetes in people with advanced kidney disease is challenging, with fluctuating glucose levels and an increased risk of unsafe low glucose levels. We now have continuous glucose monitors (CGM), which allow people to monitor glucose without painful fingerprick tests. CGM can be combined with insulin pumps to create automated insulin delivery systems (AID) that automatically deliver insulin to control glucose levels. AID systems are currently used in people with type 1 diabetes, but they are not used in people with type 2 diabetes. There is little information on how these systems might help people with diabetes and advanced kidney failure, and on dialysis.

This study will investigate whether automated insulin delivery can improve glucose levels and quality of life in people with type 2 diabetes treated with more than one insulin injection with advanced kidney failure and undergoing regular haemodialysis treatment. This study will be conducted in four UK centres and will be of a parallel design. We estimate that the trial will require 84 participants to be recruited, and 76 participants to be randomised. We aim for 64 participants across both groups to complete the trial. Participants will wear a glucose sensor at the start. In random order, half will be randomised to AID treatment while the other half will continue usual care augmented with continuous glucose monitoring. The duration of each treatment stage is 12 weeks. The study will last about 18 weeks for each participant. We will compare the glucose levels in the AID group with the usual care group to see if there is a difference. Questionnaires and interviews will help us understand participants' experiences. We will carefully monitor the safety of the participants.

Study Overview

• Status: Not yet recruiting
• Conditions: Type 2 Diabetes; Chronic Kidney Disease 5D
• Intervention / Treatment: Device: Insulin injections; Device: Omnipod 5

• Study Type: Interventional
• Enrollment (Estimated): 84
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Lalantha Leelarathna, PhD; Phone Number: +44 7984477771; Email: lalantha.leelarathna@nhs.net

Study Locations

• United Kingdom
  • Derby, United Kingdom
    • Royal Derby Hospital
    • Contact: Emma Wilmot, PhD; Email: emma.wilmot2@nhs.net
  • London, United Kingdom
    • Hammersmith Hospital
    • Contact: Lalantha Leelarathna, PhD; Email: lalantha.leelarathna@nhs.net
  • London, United Kingdom
    • Guys and St Thomas' Hospitals
    • Contact: Janaka Karalliedde, PhD; Email: janaka.karalliedde@kcl.ac.uk
    • Principal Investigator: Janaka Karalliedde, PhD
  • Manchester, United Kingdom
    • Manchester Royal Infirmary
    • Contact: Hood Thabit, PhD; Email: hood.thabit@mft.nhs.uk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Aged 18 years and older
2. Participant has insulin-treated type 2 diabetes on more than 1 insulin injection per day or insulin pump therapy
3. Participant has ESKD and is established on out-patient hospital-based haemodialysis treatment at least 3 times a week, via an arterio-venous fistula, graft or central venous catheter
4. If the participant uses a CGM, the baseline time spent between 3.9 to 10 mmol/L in the last 4 weeks is <70%
5. For those not using CGM screening HbA1c >7.0% (53 mmol/mol) and ≤ 12% (108 mmol/mol)
6. Total daily dose of insulin is > 10 units and <200 units per day
7. Literate in English for safe study conduct.
8. Willing to wear study glucose sensors and the AID system
9. Willing to follow study-specific instructions
10. Female participants of childbearing age should be on effective contraception, not sexually active / or have no plans for pregnancy
11. All patients whether transplant-wait listed or not, are eligible for inclusion.

Exclusion Criteria:

Exclusion Criteria

1. Any other physical disease or people with known severe mental illness (psychotic disorder, bipolar disorder, dementia, substance and alcohol dependence, learning disabilities, active suicidal ideation) that are likely to interfere with the normal conduct of the study and interpretation of the study results as judged by the investigator
2. Either current use of peritoneal dialysis or planned modality transfer (transplantation from a live donor with a confirmed date, peritoneal dialysis or conservative care) in the next 18 weeks
3. Only treated with background (basal) insulin
4. The participant is currently on AID or more than 2 weeks use of AID in the last 4 weeks
5. Known or suspected allergy against insulin
6. Treated with sulphonylureas (use of SGLT2 inhibitors are allowed)
7. Treated with hydroxyurea (sensor interference)
8. Presence of unstable retinopathy per Investigator's judgement
9. Severe bilateral visual impairment
10. Pregnancy, planned pregnancy in the next 3 months or breastfeeding current or planned glucocorticoid use other than inhaled/ topical use. Stable long-term steroid use is not an exclusion

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Control group (Usual Care); Usual insulin injections	Device: Insulin injections; Usual insulin injections
Active Comparator: Intervention Arm; Omnipod 5	Device: Omnipod 5; Omnipod 5 automated insulin delivery system

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time in range 3.9 to 10 mmol/l	Glucose time in range (TIR), % of readings between 3.9 to 10.0 mmol/l based on sensor glucose levels, from randomisation to 12 weeks	12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time spent below target glucose (<3.9mmol/l)	Time spent below target glucose (<3.9mmol/l)	12 weeks
Time spent below target glucose (<3.0mmol/l)	Time spent below target glucose (<3.0mmol/l)	12 weeks
Severe hypoglycaemic episodes	Severe hypoglycaemic episodes as defined by American Diabetes Association	12 weeks
Frequency of significant ketosis events (ketones >1.5)	Frequency of significant ketosis events (ketones >1.5)	12 weeks
Diabetes Treatment Satisfaction Questionnaire Score	The DTSQ is a validated, 8-item measure that evaluates respondents' satisfaction with their diabetes treatment using a 7-point Likert scale. It consists of six questions about diabetes treatment and two questions regarding the burden of hypo- and hyperglycaemia. Treatment satisfaction is scored from 0 to 36 based on the responses to the first six questions, with higher scores indicating greater satisfaction with treatment	12 weeks
Quality of life (EQ-5D-5L) Score	The EQ-5D-5L consists of two parts. The EQ-5D descriptive system is a non-disease-specific measure of health-related quality of life. Respondents evaluate their perceived health status across five dimensions, each with five levels. The results from these five dimensions can be combined into a five-digit number that describes the respondent's perceived health state. The second part is the EQ VAS, where respondents record their self-rated health on a vertical visual analogue scale with endpoints labelled 'The best health you can imagine' and 'The worst health you can imagine'.	12 weeks
Xerostomia Inventory (XI) Score	The Xerostomia Inventory (XI) assesses oral dryness and comprises 11 items, each rated on a five-point Likert scale (never = 1, to very often = 5). The responses to these 11 items are summed, resulting in an individual XI score for each patient that ranges from 11 (no dry mouth) to 55 (extremely dry mouth).	12 weeks
Type 2 Diabetes Distress Assessment System (T2-DDAS) Score	Type 2 Diabetes Distress Assessment System (T2-DDAS) - The T2-DDAS is a validated 8-item measure of diabetes distress, where respondents answer each question on a 5-point Likert scale. The core distress score is the average of the eight items on the core scale, with each item rated from 1 to 5. Mean score <2.0 indicate little or no distress Mean score ≥2.0 but not more than 2.9 indicates moderate distress Mean score ≥3.0 indicate high distress Any score > 2.0 is considered clinically significant	12 weeks
Frequency of significant ketosis events (ketones >3)	Frequency of significant ketosis events (ketones >3)	12 weeks
Dialysis Thirst Inventory (DTI) Score	Dialysis Thirst Inventory (DTI) - The DTI is a questionnaire that measures perceived thirst in individuals undergoing dialysis. It contains seven items, each with a five-point Likert-type scale (never = 1, to very often = 5). The scores are summed to produce a DTI score ranging from seven (no thirst) to 35 (very thirsty).	12 weeks

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Death	Death	12 weeks
Time above range > 10 mmol/L	Time above range > 10 mmol/L	12 weeks
Time above range > 13.9 mmol/L	Time above range > 13.9 mmol/L	12 weeks
Mean glucose levels	Mean glucose levels	12 weeks
Coefficient of variation of glucose levels	Coefficient of variation of glucose levels	12 weeks
Total Daily Dose of Insulin	Total Daily Dose of Insulin	12 weeks
Ultrafiltration volume	Ultrafiltration volume	12 weeks
Interdialytic weight gain	Interdialytic weight gain	12 weeks
Percentage of time auto-mode use	Percentage of time auto-mode use	12 weeks

Collaborators and Investigators

• Sponsor: Imperial College London
• Collaborators: King's College London; University of Nottingham; Guy's and St Thomas' NHS Foundation Trust; Manchester University NHS Foundation Trust; University Hospitals of Derby and Burton NHS Foundation Trust

Publications and helpful links

General Publications

• Lu JC, Lee P, Ierino F, MacIsaac RJ, Ekinci E, O'Neal D. Challenges of Glycemic Control in People With Diabetes and Advanced Kidney Disease and the Potential of Automated Insulin Delivery. J Diabetes Sci Technol. 2024 Nov;18(6):1500-1508. doi: 10.1177/19322968231174040. Epub 2023 May 10.

Study record dates

Study Major Dates

• Study Start (Estimated): April 1, 2026
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): April 1, 2027

Study Registration Dates

• First Submitted: February 10, 2026
• First Submitted That Met QC Criteria: February 19, 2026
• First Posted (Actual): February 20, 2026

Study Record Updates

• Last Update Posted (Actual): February 20, 2026
• Last Update Submitted That Met QC Criteria: February 19, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: Type 2 Diabetes; Haemodialysis; Chronic kidney diseases
• Additional Relevant MeSH Terms: Urogenital Diseases; Endocrine System Diseases; Pathologic Processes; Male Urogenital Diseases; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Chronic Disease; Disease Attributes; Metabolic Diseases; Glucose Metabolism Disorders; Diabetes Mellitus; Renal Insufficiency; Pathological Conditions, Signs and Symptoms; Nutritional and Metabolic Diseases; Diabetes Mellitus, Type 2; Renal Insufficiency, Chronic
• Other Study ID Numbers: 173303; NIHR207915 (Other Grant/Funding Number: National Institute for Health and Care Research)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes